21 CFR 312.55 - Informing investigators.

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There are 2 Updates appearing in the Federal Register for 21 CFR Part 312. View below or at eCFR (GPOAccess)
§ 312.55 Informing investigators.
(a) Before the investigation begins, a sponsor (other than a sponsor-investigator) shall give each participating clinical investigator an investigator brochure containing the information described in § 312.23(a)(5).
(b) The sponsor shall, as the overall investigation proceeds, keep each participating investigator informed of new observations discovered by or reported to the sponsor on the drug, particularly with respect to adverse effects and safe use. Such information may be distributed to investigators by means of periodically revised investigator brochures, reprints or published studies, reports or letters to clinical investigators, or other appropriate means. Important safety information is required to be relayed to investigators in accordance with § 312.32.
[52 FR 8831, Mar. 19, 1987, as amended at 52 FR 23031, June 17, 1987; 67 FR 9586, Mar. 4, 2002]

Title 21 published on 2014-04-01.

The following are only the Rules published in the Federal Register after the published date of Title 21.

For a complete list of all Rules, Proposed Rules, and Notices view the Rulemaking tab.

  • 2015-04-03; vol. 80 # 64 - Friday, April 3, 2015
    1. 80 FR 18087 - Food and Drug Administration Regulations; Change of Addresses; Technical Amendment
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule; technical amendment.
      This rule is effective April 3, 2015.
      21 CFR Parts 1, 26, 99, 201, 203, 206, 207, 310, 312, 314, 600, 601, 606, 607, 610, 660, 680, 801, 807, 812, 814, 822, and 1271

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United States Code

Title 21 published on 2014-04-01

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 312 after this date.

  • 2015-04-03; vol. 80 # 64 - Friday, April 3, 2015
    1. 80 FR 18087 - Food and Drug Administration Regulations; Change of Addresses; Technical Amendment
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule; technical amendment.
      This rule is effective April 3, 2015.
      21 CFR Parts 1, 26, 99, 201, 203, 206, 207, 310, 312, 314, 600, 601, 606, 607, 610, 660, 680, 801, 807, 812, 814, 822, and 1271